Category Archives: SEAS Vytorin Cancer Incidence Secret FDA Report Peto St

Ed Silverman, on a "Secret" SEAS Report to FDA — per Congressional Committees’ Letters, Today

I cannot do it justice — just go read it — and comment there.

H/T Salmon (in the comments, below)!

In any event, here’s the latest letter — in full text:

September 2, 2008

Mr. Fred Hassan
Chairman and CEO
Schering-Plough Corporation
2000 Galloping Hill Road
Kenilworth, NJ 07033

Mr. Richard T. Clark
Chairman, President, and CEO
Merck & Co., Inc.
One Merck Drive
P.O. Box 100
Whitehouse Station, NJ 08889

Dear Mr. Hassan and Mr. Clark:

Under Rules X and XI of the Rules of the U.S. House of Representatives, the Committee on Energy and Commerce and its Subcommittee on Oversight and Investigations are continuing to investigate the safety and effectiveness of Vytorin, a prescription drug manufactured by Merck and Schering-Plough.

We have received a copy of Sir Richard Peto’s consultant report on the Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) study, which was submitted to the U.S. Food and Drug Administration (FDA). At our July 22, 2008, meeting with your counsel, we were advised that Dr. Peto’s report would provide a complete assessment of Vytorin’s association with cancer in the SEAS study and provide a full review of available data. After reviewing the five-page report, however, we were somewhat surprised to discover that the report contains little more than the information that was presented at the July 21, 2008, press conference announcing the SEAS results. We are also at a loss to understand why this report was kept by you from our Committee and the public.

We are concerned that an esteemed scientific consultant to Merck and Schering-Plough may have generated a secret report to FDA—a report whose contents may have been misrepresented to our staff as the report itself appears to contain information which is publicly available. Therefore, we ask that you provide answers to the following questions in writing:

1. Is the attached report the totality of Dr. Peto’s submission to FDA?

2. Why was Dr. Peto’s consultant study not made publicly available?

3. When did Merck, Schering-Plough, the Merck/Schering-Plough joint venture, or any of their agents, attorneys, or lobbyists first contact Dr. Peto about his consultant report?

4. When was Dr. Peto’s report submitted to FDA?

5. Was Dr. Peto’s report reviewed or edited prior to its submission to FDA by anyone from Merck, Schering-Plough, the Merck/Schering-Plough joint venture, or any of their agents, attorneys, or lobbyists? Please supply any drafts and all other documents that describe the review or editing of the report.

6. Has Dr. Peto prepared any other analysis of the association (or lack thereof) between Vytorin and cancer for any other regulatory agency or peer-review journal?

7. What role, if any, did Merck, Schering-Plough, the Merck/Schering-Plough joint venture, or any of their agents, attorneys, or lobbyists have in the preparation of the attached Peto report and decision to submit it to FDA?

Finally, we ask that you make Dr. Peto available for a staff interview as soon as possible.

Please deliver copies of your responses to the Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce, Room 316, Ford House Office Building, no later than two weeks from the date of this letter. After review of your response, we may require additional records and/or staff interviews with company officials.

Thank you for your prompt attention to this matter.

Sincerely,

Perhaps the most-ominous development in this letter is the escalating sense that Chairmen Dingell and Stupak now believe Schering (and/or its counsel) has been less than candid in responding to the Congressional Committees’ processes. This is the sort of stuff that leads to Congressional subpoenas — and ultimately — indictments, if the subpoenas are unavailing.

[Here’s the August 21, 2008 letter — in full text.]